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NCT Number: NCT04089787

Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.

Three to five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.

The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6%.

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Key information

Conditions

Community-Acquired Pneumonia Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Infections Lung Diseases Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and/or CT scan and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
  • Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate
  • Age ≥ 18 years
  • Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization
  • Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%)

Exclusion criteria

  • Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
  • Hospitalization during the previous 14 days
  • Antibiotic treatment (>2 days) within the past 30 days, directed at lower respiratory tract pathogens
  • Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
  • Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
  • Pleural empyema or lung abscess
  • Pleural effusion requiring drainage tube
  • Intensive care unit (ICU) admittance
  • Pregnancy and breastfeeding

Treatment and study plan

Intervention

Other

Shortened antibiotic treatment of 5 days

Control

Other

Antibiotic treatment of 7 days or longer at the discretion of the treating physician

Primary outcomes

  1. 90-day survival

    Time frame: within 90 days

Secondary outcomes

  1. Duration of antibiotic treatment

    Time frame: within 90 days

    Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy

  2. Length of hospital stay

    Time frame: within 90 days

    Days from the date of hospital admission for pneumonia to the date of discharge

  3. Antibiotic adverse events

    Time frame: within 90 days

    Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia

  4. Serious adverse events

    Time frame: within 90 days

    Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

  5. Major complications

    Time frame: within 90 days

    Number of participants with major complications, including pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, and intensive care unit (ICU) admission

  6. Use of antimicrobials after discharge

    Time frame: within 90 days

    Days of antibiotic treatment for any reason after hospital discharge

  7. Post-discharge follow-up visits

    Time frame: within 90 days

    Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner

  8. Readmissions

    Time frame: days 30 and 90

    Number of participants with readmissions for reasons related to or unrelated to pneumonia

  9. Mortality

    Time frame: in-hospital, days 30 and 90

    Number of deaths by any cause

Sponsors and collaborators

Lead sponsor

Thomas Benfield

Other

Registry information

Official study title

Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial

Acronym: CAP5

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2019
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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